The newest medical device manufacturer on the scene may be a little surprising: CVS Health. The company, known for its pharmacy chains, is developing a new home hemodialysis medical device—a move, company officials say, that will position CVS as a “positive disruptor in the field with the ability to help reshape and redefine the kidney care space.”

“In dialysis today, there is an enormous unmet medical need with high levels of mortality, frequent hospitalizations and poor quality of life for affected patients,” says Alan Lotvin, MD, executive vice president and head of CVS Specialty. “As we explored this area, it became clear that our enterprise assets from our experience with complex patient home care through Coram, the breadth of our chronic disease management capabilities with CVS Specialty and Accordant, and our deep payor relationships at CVS Caremark will enable us to create a unique value proposition to help reshape dialysis treatment.”

CVS Health will be approaching this new initiative in a staged approach with phases focused on early disease identification and patient education, followed by the development of a comprehensive home dialysis program, for both hemodialysis and peritoneal dialysis. As part of the home dialysis program, CVS Health will be initiating a clinical trial to demonstrate the safety and efficacy of a new home hemodialysis device in support of a planned FDA submission to obtain market clearance.

The device has been designed with features intended to make home hemodialysis easier for patients, in order to facilitate longer, more frequent treatments. After all, CVS officials say, in published clinical research, longer, more frequent hemodialysis treatments lead to better outcomes in appropriate patient populations.

“While in-center dialysis clinics are currently the most common choice for hemodialysis treatment, published clinical research has shown improved cardiac health, metabolic control, and survival for patients who are treated with longer, more frequent dialysis treatments. This treatment paradigm is best delivered in the convenience of a patient’s home,” says Bruce Culleton, MD, vice president and chief medical officer, CVS Specialty.

“CVS Health is uniquely positioned to build a solution that will enable us to identify and intervene earlier with patients to optimize the management of chronic kidney disease, while at the same time making home dialysis therapies a real option for more patients,” Culleton adds.